Cognitive ImpairmentNEUROFALLNCT07507812
Fall Prevention in Mild Cognitive Impairment
A study testing Virtual Neurophysiological Rehabilitation in people with Cognitive Impairment and High Fall Risk, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, High Fall Risk
- What is being tested?
- Virtual Neurophysiological Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- community dwelling
- at risk for falls as indicated by answering yes to one of the following: 1) have you fallen in the last year? 2) four square step test time > 15 seconds 3) are you worried about falling?
- cognitive impairment as indicated by either 1) clinical diagnosis 2) MOCA score of 10-25
- able to provide written consent
Who cannot join
- MOCA <10 or clinically diagnosed dementia
- inability to participate in a virtual intervention
- serious visual or hearing problems
- stroke with hemiparesis or severe neurological disease
- current use of medications affecting mental state
- current active participation in programs related to balance or mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Jamie Giffuni, MD BA, 410-605-7000 ext. 4840, jamie.giffuni@va.gov
Alyssa D Stookey, PhD MS
About this study
Official title: Fall Prevention in Cognitively Impaired Older Veterans Through Neurophysiological Rehabilitation
Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. The purpose of this study is to test the effects of 6 weeks of a virtual tele-neurorehabilitation intervention on fall prevention, functional mobility, strength, cognition and performance of activities of daily living. Participants will be one of 28 participants in the VA Maryland Health Care System. Participation in the study is voluntary and the research will be conducted at the VA Maryland Health Care System. The entire study will take approximately 2 years to complete. Subject's participation in the study will last 3 months.
Read the detailed description
Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. This pilot aims to determine the feasibility and effectiveness of a virtual neurorehabilitation intervention to improve functional mobility, strength, cognition and performance of activities of daily living in a cohort of 28 older Veterans with cognitive impairment. The overall goals are to improve fall risk in a population for which traditional rehabilitation programs may not be feasible. The investigators envision a neurorehabilitation model that can be readily exportable and widely implemented at other VA facilities with minimal resources as an enhancement to clinical care for fall prevention.
- Conditions
- Cognitive Impairment, High Fall Risk
- Being tested
- Virtual Neurophysiological Rehabilitation
- Keywords
- neurorehabilitation, function, mobility
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Neurophysiological RehabilitationBehavioural
Combining active observation (AO) and motor imagery (MI)
| Study group | Role | What they receive |
|---|---|---|
| Group | Experimental | There will be no group assignments in this pilot study and all participants will receive the intervention. Receives: Behavioral: Virtual Neurophysiological Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Adherence
Number of sessions attended
Measured: 6 weeks
Secondary outcomes (2)
Change in Four Square Step Test time
Time to complete the Four Square Step Test
Measured: 6 weeks
Change in 30 second chair stand test
Number of unassisted chair rises completed in 30 seconds
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be no group assignments in this pilot study and all participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyssa D Stookey, PhD MS, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507812
- Sponsor's protocol ID
- RRD6-001-25M
- Other IDs
- 1I21RD000591-01A1
- Acronym
- NEUROFALL
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention in Cognitively Impaired Older Veterans Through Neurophysiological Rehabilitation
- ClinicalTrials.gov ID
- NCT07507812
- Acronym / sponsor ID
- NEUROFALL / RRD6-001-25M
- Conditions
- Cognitive Impairment, High Fall Risk
- Keywords
- neurorehabilitation, function, mobility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. The purpose of this study is to test the effects of 6 weeks of a virtual tele-neurorehabilitation intervention on fall prevention, functional mobility, strength, cognition and performance of activities of daily living. Participants will be one of 28 participants in the VA Maryland Health Care System. Participation in the study is voluntary and the research will be conducted at the VA Maryland Health Care System. The entire study will take approximately 2 years to complete. Subject's participation in the study will last 3 months.
Detailed description
Falls represent the leading cause of hospitalization, nursing home admissions, disability and mortality for older adults with annual healthcare costs over $50 billion. Older Veterans with cognitive impairment are at an increased risk of falls and injurious fall. This pilot aims to determine the feasibility and effectiveness of a virtual neurorehabilitation intervention to improve functional mobility, strength, cognition and performance of activities of daily living in a cohort of 28 older Veterans with cognitive impairment. The overall goals are to improve fall risk in a population for which traditional rehabilitation programs may not be feasible. The investigators envision a neurorehabilitation model that can be readily exportable and widely implemented at other VA facilities with minimal resources as an enhancement to clinical care for fall prevention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be no group assignments in this pilot study and all participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Group | Experimental | Behavioral: Virtual Neurophysiological RehabilitationThere will be no group assignments in this pilot study and all participants will receive the intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- community dwelling
- at risk for falls as indicated by answering yes to one of the following: 1) have you fallen in the last year? 2) four square step test time > 15 seconds 3) are you worried about falling?
- cognitive impairment as indicated by either 1) clinical diagnosis 2) MOCA score of 10-25
- able to provide written consent
Key exclusion criteria (6 listed)
- MOCA <10 or clinically diagnosed dementia
- inability to participate in a virtual intervention
- serious visual or hearing problems
- stroke with hemiparesis or severe neurological disease
- current use of medications affecting mental state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Neurophysiological RehabilitationCombining active observation (AO) and motor imagery (MI) | Behavioural | Group |
Primary outcome
Program Adherence
Time frame: 6 weeks
Number of sessions attended
2 secondary outcomes
Change in Four Square Step Test time
Time frame: 6 weeks
Change in 30 second chair stand test
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alyssa D Stookey, PhD MS principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Neurophysiological Rehabilitation in people with Cognitive Impairment and High Fall Risk, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa D Stookey, PhD MS ((410) 605-7000 ext. 5431, alyssa.stookey@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Adherence (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.